臨床研究等提出・公開システム

Treatment method of lymph node metastasis by lymphatic drug delivery system-phase I study evaluating the safety of the method

Phase I study of the lymphatic drug delivery system (LDDS)

Katagiri Katsunori

Iwate Medical University Hospital

Yahaba-cho, Shiwa-gun, Iwate

kkatagir@iwate-med.ac.jp

Shiga Kiyoto

Iwate Medical University

Yahaba-cho, Shiwa-gun, Iwate

+81-19-613-7111

kshiga@iwate-med.ac.jp

Pending

Nov. 22, 2023

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) diagnosed with head end neck cancer by histopathological or cytological examination and having lympn
node metastases in the neck.
2) neck dissection is planned
3) aged 18 or older
4) written informed consent is obtained by patients themselves

1) invasion of the cancer to the neck
2) alllergy to the drug used in this study
3) patients who are judged to be unsuitable for this study by the physician

Both

Head and neck cancer

puncture the targert metastatic lymph node guided under sonography and inject the anti-tumor agent adjusted for LDDS.

head and neck cancer, lymph node metastasis

lymphatic drug delivery system (LDDS)

D000077195

ID: D007272

Frequencies of the adverse events such as complication and allergic response before and after the injection procedure of anti-tumor agent prepared for LDDS.

Histopathological evaluation of the treatment results for metastatic lymph nodes based on Oh-hoshi-Shimosato classification.

+81-19-651-5111

Oct. 04, 2023

No

none